Events

Recall of LMP50 (Lesser Metatarsal Phalangeal Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tornier, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52886
  • Event Risk Class
    Class 2
  • Event Number
    Z-0455-2010
  • Event Initiated Date
    2009-04-06
  • Event Date Posted
    2009-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84222
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Toe Polymer Constrained Prosthesis - Product Code KWH
  • Reason
    Tornier, inc. has received a report of a mislabeled product due to a product mix-up. the package label indicated that the product was a model lmp-50 however the product inside the package was tornier fgt-50 implant (primus flexible great toe implant with grommetts).
  • Action
    Consignees were sent on April 6, 2009 a Tornier "Urgent-Product Recall" letter dated April 3, 2009. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.

Device

LMP50 (Lesser Metatarsal Phalangeal Implant
  • Model / Serial
    Lot number: K10747, K10677, and K10510.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France.
  • Product Description
    Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435. || The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint.
  • Manufacturer
    Tornier, Inc.

Manufacturer

Tornier, Inc.
  • Manufacturer Address
    Tornier, Inc., 3601 W 76th Street, Suite 200, Edina MN 92121-1204
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA